BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FDR GO

    MDR report key: 22368662 · Received July 1, 2025

    Report

    Report Number
    8030233-2025-00002
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    May 20, 2025
    Report Date
    July 1, 2025
    Manufacturer
    SHIMADZU COPORATION
    Product Code
    IZL
    PMA / PMN Number
    K080701
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION FROM FUJIFILM, IT IS HIGHLY PROBABLE THAT THE CABLE CONNECTED TO THE BATTERY OF THE PRINTED CIRCUIT BOARD (MUX POWER BOARD) AND THE POWER CABLE OF THE DR DEVICE WERE DISCONNECTED WHILE THE MAIN BREAKER (NFB2) OF THE DEVICE WAS NOT TURNED OFF. AS A RESULT, THE PIN OF THE CONNECTOR "JDR" ON THE PRINTED CIRCUIT BOARD WAS EXPOSED, AND THE TERMINAL OF THE CABLE TO THE BATTERY, WHICH WAS ENERGIZED, CONTACTED AND SHORT-CIRCUITED THE PIN OF "JDR," CAUSING AN ARC, RESULTING IN BURN INJURY. WE JUDGE THAT THERE WAS NO FAILURE IN THE DEVICE FOR THE FOLLOWING REASONS. (1) ACCORDING TO 1 - THE PRINTED CIRCUIT BOARD TO WHICH HIGH VOLTAGE IS APPLIED, INCLUDING THIS BOARD, IS COVERED WITH AN ACRYLIC PLATE. WHEN REPLACING THE PRINTED CIRCUIT BOARD, THE ACRYLIC PLATE MUST BE REMOVED. A WARNING LABEL INDICATING THAT 240 V IS APPLIED AT ALL TIMES AND A WARNING LABEL INDICATING THAT THE MAIN BREAKER SHOULD BE TURNED OFF AND THE CONDENSER SHOULD BE DISCHARGED BEFORE TOUCHING; THE INSIDE ARE ATTACHED TO THE ACRYLIC PLATE TO WARN SERVICE PERSONS. (2) ACCORDING TO 2 - THE INSTALLATION MANUAL, WHICH INCLUDES THE MAINTENANCE AND INSPECTION DETAILS, INSTRUCTS TO TURN OFF THE MAIN BREAKER WHENEVER THE DEVICE COVER IS REMOVED FOR REPAIR AND MAINTENANCE. IN ADDITION, SINCE A LARGE-CAPACITY CAPACITOR IS MOUNTED IN THE DEVICE, IT IS INSTRUCTED TO OPERATE AFTER SUFFICIENT DISCHARGE. AS DESCRIBED ABOVE, PROCEDURES AND WARNINGS TO PREVENT ACCIDENTS DUE TO ELECTRIC SHOCKS AND SHORT CIRCUITS WERE INDICATED ON THE DEVICE AND THE INSTALLATION MANUAL, AND IF THE OPERATION HAD BEEN PERFORMED IN ACCORDANCE WITH THE PROCEDURES, THE ACCIDENT WOULD NOT HAVE OCCURRED. WE HAVE JUDGED THAT THERE IS NO PROBLEM IN THE DEVICE ITSELF AND THAT MEASURES TO THE DEVICE ARE UNNECESSARY.

    Description of Event or Problem · 0

    WE RECEIVED THE FOLLOWING REPORT FROM FUJIFILM. DURING REPAIR WORK ON THE FDR GO (SERIAL NUMBER: (B)(6)) DUE TO A BATTERY CHARGING PROBLEM, A SERVICE PERSON SUFFERED BURNS OF UP TO 3 DEGREES ON THE INDEX AND MIDDLE FINGERS OF HIS RIGHT HAND WHILE REMOVING A PRINTED CIRCUIT BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1430750 FDR GO System, x-ray, mobile IZL SHIMADZU COPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other